HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors. Values for all analytes are within the normal range.

Device Description

AI/ML Overview

The provided text describes the HemosIL Normal Control ASSAYED device and its performance study. Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the within-run %CV. Instead, it presents the results of a precision study. For the purpose of this response, the "reported device performance" will be the "Within-Run %CV" from the study, and if acceptance criteria were explicitly stated, they would be listed alongside these values. Since they are not, we assume the presented values are deemed acceptable for substantial equivalence.

Analyte	Reported Device Performance (Within-Run %CV)	Acceptance Criteria (Not explicitly stated in the document)
Activated Partial Thromboplastin (APTT)	1.87	N/A
Antithrombin	2.10	N/A
Factor V (Extrinsic)	4.47	N/A
Factor VIII (Intrinsic)	6.36	N/A
Fibrinogen - Clauss	2.79	N/A
Fibrinogen - PT-Based	4.62	N/A
Plasmin Inhibitor	1.05	N/A
Plasminogen	1.38	N/A
Protein C	2.98	N/A
Protein S	1.84	N/A
Prothrombin Time (PT)	1.58	N/A
Thrombin Time	1.54	N/A

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (n):
- For most analytes (APTT, Antithrombin, Factor V, Factor VIII, Fibrinogen - Clauss, Fibrinogen - PT-Based, Protein C, Prothrombin Time, Thrombin Time): n = 80
- For Plasmin Inhibitor, Plasminogen, Protein S: n = 40
Data Provenance: The document states the control is "prepared using human citrated plasma from healthy donors." It does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a precision study for a control substance, it's highly likely to be prospective data collected specifically for this performance assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a quality control material for coagulation assays, not an AI or diagnostic imaging device that requires expert review for ground truth. The "ground truth" for a control material is its expected value or range, established through rigorous manufacturing processes and internal validation, and compared against its own performance parameters (like precision). Therefore, these concepts of "experts establishing ground truth" are not applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this is a quality control material, not a diagnostic or screening device that requires adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a quality control material and not a device that involves human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a quality control material, not an algorithm, and the performance described is intrinsic to the material itself and the analytical system it's used on.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a quality control material, the "ground truth" is typically established by:

Manufacturing specifications: The intended concentration or activity levels of the analytes.
Reference methods/labs: Testing the control material using highly accurate and precise reference methods or in reference laboratories to assign target values and ranges before it is marketed.
Internal validation: Extensive testing by the manufacturer to define its own performance characteristics (like precision and stability), which are then compared to its intended use and regulatory requirements.

The document implies this "ground truth" through the "Mean" values provided in the table, which are the expected values for the control.

8. The sample size for the training set

Not applicable. This device is a quality control material, not an AI/machine learning algorithm that requires a training set. The "precision study" described is a performance validation, not a training process.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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K021023

Section 3 HemosIL Normal Control - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207

Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

March 28, 2002

Name of the Device(s):

HemosIL Normal Control ASSAYED

Classification Name(s):

Common Name	Plasma Coagulation Control
Product Code	81GGN
Regulation Number	21 CFR 864.5425
Classification	Class II

Identification of Predicate Device(s):

K002400 Assess™ Normal Control NOTE: Control was 510(k) cleared as part of analyzer systems, most recently the ACL Advance.

Description of the Device/Intended Use(s):

Statement of Technological Characteristics of the Device Compared to Predicate Device:

HemosIL Normal Control is substantially equivalent to the predicate device in performance, intended use and safety and effectiveness.

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Section 3 (Cont.) HemosIL Normal Control - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

A precision study was performed with HemosIL Normal Control over multiple days with multiple runs using specific lots of IL reagents on IL instrumentation:

Analyte	n=	Mean(n=80)	Within-Run%CV
Activated Partial Thromboplastin (APTT)(Seconds)	80	28.0	1.87
Antithrombin(% Activity)	80	110	2.10
Factor V (Extrinsic)(% Activity)	80	96.4	4.47
Factor VIII (Intrinsic)(% Activity)	80	89.6	6.36
Fibrinogen - Clauss(mg/dL)	80	400	2.79
Fibrinogen - PT-Based(mg/dL)	80	329	4.62
Plasmin Inhibitor(% Activity)	40	99	1.05
Plasminogen(% Activity)	40	109	1.38
Protein C(% Activity)	80	114	2.98
Protein S(% Activity)	40	97.8	1.84
Prothrombin Time (PT)(Seconds)	80	10.1	1.58
Thrombin Time(Seconds)	80	13.0	1.54

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three human profiles incorporated into its design, suggesting a connection between health, human services, and the nation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: K021023

Trade/Device Name: HemosIL Normal Control ASSAYED Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 28, 2002 Received: March 29, 2002

Dear Ms. Marble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 Jour de 100 to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso o ac noved a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

HemosIL Normal Control ASSAYED Device Names:

Indications for Use:

Values for all analytes are within the normal range.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)	(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K021023
Prescription Use(Per 21 CFR 801.019)	OR	Over-The-Counter Use

Section 2 HemosIL Normal Control 510(k) Page 1 of 1

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.